Best practices for selection of excipients for paediatrics - Workshop reflection

Area of Science:

• Pharmaceutical Sciences
• Paediatric Drug Development
• Formulation Science

Background:

• Developing age-appropriate paediatric formulations is a key pharmaceutical industry focus, significantly impacting excipient selection.
• Ensuring the safety and tolerability of excipients is a major challenge in paediatric formulation.
• Regulatory bodies require clear justification and rationale for excipient choices based on target age, route, and dosage form.

Purpose of the Study:

• To understand current practices and challenges in selecting excipients for paediatric formulations.
• To reflect on the risk-benefit analysis approach for excipients in paediatric drug development.
• To compare paediatric excipient selection considerations with those for other age groups.

Main Methods:

• A workshop organized by the European Paediatric Formulation Initiative (EuPFI) was conducted.
• Discussions focused on current scenarios, practices, and regulatory aspects of excipient selection.
• Participants shared insights on differences in excipient selection for paediatric versus non-paediatric formulations.

Main Results:

• Key factors influencing excipient selection include target age, route of administration, and dosage form.
• The principle of benefit-to-risk balance is essential for assessing excipient suitability in paediatric populations.
• Workshop discussions highlighted the need for a systematic strategy and identified areas for best practice recommendations.

Conclusions:

• Recommendations and questions emerged from the workshop regarding excipient selection in paediatric drug development.
• These recommendations serve as a foundation for a more systematic approach to selecting excipients for paediatric formulations.
• Further refinement of strategies is needed to optimize excipient use in paediatric medicines.